uu.seUppsala University Publications
Change search
ReferencesLink to record
Permanent link

Direct link
Summary workshop report: bioequivalence, biopharmaceutics classification system, and beyond
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmacy.
Show others and affiliations
2008 (English)In: AAPS Journal, ISSN 1550-7416, Vol. 10, no 2, 373-379 p.Article in journal (Refereed) Published
Abstract [en]

The workshop "Bioequivalence, Biopharmaceutics Classification System, and Beyond" was held May 21-23, 2007 in North Bethesda, MD, USA. This workshop provided an opportunity for pharmaceutical scientists to discuss the FDA guidance on the Biopharmaceutics Classification System (BCS), bioequivalence of oral products, and related FDA initiatives such as the FDA Critical Path Initiative. The objective of this Summary Workshop Report is to document the main points from this workshop. Key highlights of the workshop were (a) the described granting of over a dozen BCS-based biowaivers by the FDA for Class I drugs whose formulations exhibit rapid dissolution, (b) continued scientific support for biowaivers for Class III compounds whose formulations exhibit very rapid dissolution, (c) scientific support for a number of permeability methodologies to assess BCS permeability class, (d) utilization of BCS in pharmaceutical research and development, and (e) scientific progress in in vitro dissolution methods to predict dosage form performance.

Place, publisher, year, edition, pages
2008. Vol. 10, no 2, 373-379 p.
National Category
Pharmaceutical Sciences
URN: urn:nbn:se:uu:diva-100028DOI: 10.1208/s12248-008-9040-9ISI: 000259133600018PubMedID: 18679807OAI: oai:DiVA.org:uu-100028DiVA: diva2:209203
Available from: 2009-03-24 Created: 2009-03-24 Last updated: 2010-11-10Bibliographically approved

Open Access in DiVA

No full text

Other links

Publisher's full textPubMed
By organisation
Department of Pharmacy
In the same journal
AAPS Journal
Pharmaceutical Sciences

Search outside of DiVA

GoogleGoogle Scholar
The number of downloads is the sum of all downloads of full texts. It may include eg previous versions that are now no longer available

Altmetric score

Total: 213 hits
ReferencesLink to record
Permanent link

Direct link